Monday, February 03, 2025 10:51:14 AM
The program was clearly explained last year by the outgoing CEO of MHRA when she discussed "highly personalized" treatments.
They are talking about vaccines being made by computer analysis of genetic makeup of the tumor. By current regulator practice, that would make every dose a different drug and thus could never be approved. This is a framework discussion on how to regulate these.
The only reason MRNa is being mentioned is that is the only tech currently in play in the space. But the program would be applied to any other program using the same concept of creating a different vaccine per person based on genetics, regardless of underlying common tech.
They are talking about vaccines being made by computer analysis of genetic makeup of the tumor. By current regulator practice, that would make every dose a different drug and thus could never be approved. This is a framework discussion on how to regulate these.
The only reason MRNa is being mentioned is that is the only tech currently in play in the space. But the program would be applied to any other program using the same concept of creating a different vaccine per person based on genetics, regardless of underlying common tech.
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